TeleHealth Resistance exercise Intervention to preserve dose intensity and Vitality in Elder breast cancer patients (THRIVE)

项目摘要/摘要 2020年，超过276480名妇女被诊断患有乳腺癌，其中12万例发生在 65岁或以上的女性。鉴于美国人口年龄中位数的增加，乳腺癌的数量 在接下来的几十年里，老年妇女的确诊人数预计将增加50%。患有乳腺癌的老年妇女 与年轻女性相比，乳腺癌患者的预后更差，治疗不足的可能性很大 发挥核心作用。研究表明，接受治疗的乳腺癌患者85%的接受治疗 剂量强度(RDI)，一种将给药总剂量与遵守计划的剂量相结合的指标 治疗计划，与女性相比，10年后疾病复发的风险增加57% 获得至少85%的RDI。只有50%-76%的乳腺癌患者获得了RDI；85，这主要是由于 这些患者的治疗毒性增加。减少与治疗相关的毒性以增强RDI 对于改善日益增长的老年乳腺癌患者的疾病结局至关重要。 为此，预测严重化学毒性的模型表明，一些潜在的可修改 因素(通常作为老年评估的一部分进行评估)是化学毒性的重要决定因素， 包括功能、抑郁和跌倒(或使用辅助设备)。锻炼有很大的积极影响 在普通人群和癌症患者中，对这些可改变因素中的每一个都有影响。然而，关于 运动干预提高老年乳房治疗耐受性和维持剂量强度的能力 癌症患者是缺乏的。我们提出了一项随机对照试验来评估 多组分、混合式远程保健(TH)运动和蛋白质摄取支持(Thrive干预) RDI、化疗毒性发生率和严重程度、功能状态、肌肉质量和患者 报道了270名年龄在≥65岁的乳腺癌患者接受新辅助化疗的结果。 参与者将被随机分为Thrive干预组或健康教育和支持对照组 一群人。干预将通过一种混合模式提供，利用现有的乳腺癌权重 损失(BWEL)试用呼叫中心。在两次面对面的现场练习后，我们将过渡到TH课程 在研究提供的平板电脑上提供，由认证的运动教练提供，他们将量身定做行为改变以支持 依从性相对于症状负担。为了优化干预效果，参与者将接受 与注册营养师一起评估饮食充分性，重点是每日蛋白质的最佳摄入量。蛋白 如果需要，将提供补充，以达到每天1.2克/公斤的摄入量。这一焦点巩固了 在久负盛名的呼叫中心(BWEL)拥有专业知识，提升了在 美国，包括癌症治疗中心，病人太少，不配配备必要的人员。该项目还 旨在评估干预成本，以及实施该计划的促进者和障碍 干预，目标是在成功完成Thrive试验后转化为临床实践。

Project Summary/Abstract More than 276,480 women were diagnosed with breast cancer in 2020, with 120,000 cases occurring in women 65 years or older. Given the increasing median age of the US population, the number of breast cancers diagnosed in older women is expected to rise by 50% in the coming decades. Older women with breast cancer experience worse breast cancer-specific outcomes as compared to younger women, under-treatment is likely to play a central role. Studies have demonstrated that breast cancer patients who receive <85% of received dose intensity (RDI), a metric that combines the total dose administered with adherence to the planned treatment schedule, have a 57% increase in the risk of disease recurrence at 10 years as compared to women who receive at least 85% RDI. Only 50-76% of breast cancer patients >65 receive an RDI >85, largely due to increased toxicity of therapy in these patients. Reducing treatment-related toxicity to enhance RDI is critical to improving disease outcomes among the growing population of older breast cancer patients. To this end, models predicting for severe chemotoxicity demonstrate that a number of potentially modifiable factors (commonly assessed as part of the geriatric assessment), are important determinants of chemotoxicity, including function, depression, and falls (or use of assistive devices). Exercise has a significant positive impact on each of these modifiable factors, in the general population and in cancer patients. However, data on the ability of exercise interventions to improve treatment tolerance and preserve dose intensity among older breast cancer patients are lacking. We propose a randomized controlled trial to assess the effects of a multicomponent, hybrid telehealth (TH) exercise and protein intake support (the THRIVE Intervention) on RDI, incidence and severity of chemotoxicities, functional status, muscle mass, and patient reported outcomes in 270 breast cancer patients age ≥ 65 receiving neo/adjuvant chemotherapy. Participants will be randomized to the THRIVE Intervention or to a Health Education and Support control group. The intervention will be delivered through a hybrid model, leveraging the existing Breast Cancer Weight Loss (BWEL) Trial call center. After 2 in-person, onsite exercise sessions, we will transition to TH sessions delivered on study provided tablets, by certified exercise coaches who will tailor behavior change to support adherence relative to symptom burden. To optimize intervention effectiveness, participants will undergo a TH evaluation of diet adequacy with a registered dietitian, focused on optimal daily protein intake. Protein supplementation will be provided if needed to achieve 1.2 gm/kg daily intake. The TH focus consolidates expertise at a well-established call center (BWEL), elevating the potential for broad implementation across the U.S., including cancer treatment centers with too few patients to justify necessary personnel. The project also seeks to evaluate intervention cost, as well as the facilitators and barriers to implementation of this TH intervention, toward the goal of translation to clinical practice upon successful completion of the THRIVE trial.